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NCT06310642 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
A Phase 4 study, sponsored by CHRISTUS Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT06310642: Completed Phase 4 study, sponsored by CHRISTUS Health.
NCT06310642 is a Phase 4 study that has completed, run by CHRISTUS Health. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06310642, a Phase 4 study, has completed, sponsored by CHRISTUS Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.
Primary Outcome
The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. The primary outcome was the difference in mean LLAMS scores between the prochlorperazine and placebo groups (t-tests). Previously validated Lake Louise Acute Mountain Sickness Score (LLAMS) were utilized. Categorical variables were an
Interventions
- DRUG Diphenhydramine
- OTHER Immediate descent from altitude.
- DRUG Prochlorperazine 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2023-03-13 |
| Phase | Phase 4 |
What the finished NCT06310642 record still lists
NCT06310642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Diphenhydramine is the first listed.
NCT06310642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06310642 about?
NCT06310642 is a clinical study titled "Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness". A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Lou...
What is the current status of trial NCT06310642?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2021-05-20. Estimated completion is 2023-03-13.
What interventions are being tested in trial NCT06310642?
The interventions under investigation include: Diphenhydramine (DRUG), Immediate descent from altitude. (OTHER), Prochlorperazine 10 mg (DRUG).
Who is sponsoring clinical trial NCT06310642?
This trial is sponsored by CHRISTUS Health, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06310642's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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